The following data is part of a premarket notification filed by Ge Hungary Kft with the FDA for Advantagesim Md With Ct Atlas-based Contouring And Re-planning Options.
| Device ID | K132045 |
| 510k Number | K132045 |
| Device Name: | ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | GE HUNGARY KFT 3000 N GRANDVIEW DIVISION: DBA GE HEALTHCARE Waukesha, WI 53188 |
| Contact | Stephen Slavens |
| Correspondent | Stephen Slavens GE HUNGARY KFT 3000 N GRANDVIEW DIVISION: DBA GE HEALTHCARE Waukesha, WI 53188 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-02 |
| Decision Date | 2013-09-04 |
| Summary: | summary |